Guidelines; COVID-19; Medical approaches; Pandemic attacks

Guidelines are very important lifesaving procedures that can affect whole medical approaches, radically. On the other hand, the controversial guidelines based on agreements and hastiness can cause mis-information production, mistrust, and even a significant increase in morbidity and mortality rate, (un-)intentionally [1-3].

There are 5 different guideline types known: 1. Good, 2. Bad, 3. Agreed, 4. Complex, 5. Controversial furthermore, used ones might applied separately of in combination simultaneously. In research and development guidelines. Maybe recent COVID-19 guidelines, one is observing that used guidelines were separately and/or randomly used, in the last three years. For instance, bad, controversial, complex procedures and guidelines, which nobody was agreed on it, in a rushed method. Confusingly, unknown was/remained, which existing good guidelines could cover COVID-19 pandemic attacks, at once. Subsequent anxiety from COVID-19 variants, among the Researchers and Clinicians has recurrently resulted in hasty and random changes to their clinical practices, and hospital triage choices, many of which were not evidence-based, and frequently harmful for patients, unusually. There have been wide variations in the propagated guidelines, at global and regional levels concerning management associated with the diagnostics sampling and testing, following standard protocols, carrying out investigations, either basic or clinical pilot studies, as well as the use of various interventions in treating patients in the intensive care units, because of the complexity of new variants side effects, and correlated guidelines [1-4], where no good guidelines could be settled on them. Interesting approaches were done by Pramesh et al. 2021 suggested 10 wise guidelines, which were so-called wisely chosen the first two recommendations. The first two recommendations are most relevant in regions of high community spread and low vaccine coverage, whereas the remaining eight guidelines are relevant regardless of the setting [1]. After decades of research and studies on the coronaviruses and production of superbugs i.e., COVID-19 variants released from 2019 caused more than 6 million death and 450 million contaminations and counting (March 2022); one of the main strategies to approach COVID-19 was having a good standard guideline to use as preventing mean for prognosis- diagnosis- treatment of the Wuhan’s infectious-unknown antigens so-called COVID-19. Paradoxically, there were no good guidelines available to be used against it, fittingly. With old good and agreed guidelines, Basic Scientists tried to describe complex-controversial guidelines, based on rapid spreading, from March 2020. Certain FDA and CDC managers did as they knew all information about COVID-19, and tried to make convinced agreed guidelines, based on own old knowledge, (un-)intentionally. Next-generation might never show understanding/accepting why the FDA and the CDC then, could not estimate COVID-19 superbugs variants virulence, accurately. They got all developed quality control and quality assurance management system, eventually. One sincere question is remaining why a coronavirus was mutated into superbugs? and could/can mutate more than two variants per month? How is possible that the primary guidelines were all underestimated these superbugs between 2019 up to 2022? Who is now to blame? One might speculate that the main producers and associated group, who gave permission to carry out pilot studies in normal laboratories without appropriate protection and facilities, who were not aware of the impact on global health and diseases progression, are innocent. Which guidelines were agreed to be used then? and why directly responsible managers still have no explanation for escaping COVID-19 superbugs variants from their laboratory?

Historically is regulated that all Medical Scientific pilotstudies should be registered. Because of their dangerous impact on Researchers' health and their environment, every scientist knows that it is important to follow them up, certainly the specific good guidelines, and not complex and controversial ones.

Now after 2022, One might speculate that these procedures did not take place, when coronavirus was used to produce superbugs COVID-19 from it. There are so many doubts and question remaining about (un-)intentionally produced COVID-19 variants from corona normal viruses that it couldn’t be ignored, however. The main question is what was the standard procedure in their laboratories then? Which controversial guidelines there were carried out? And which agreed guidelines were ignored?

When reviewing one or two clinical reports from the last two years; One is observing that for example, in this report the authors and researchers just were going to describe side effects of vaccines and medicines in the different patients, using a random protocol and guideline. “They were/are assessing the clinical and laboratory features of 11 patients in Germany and Austria in whom thrombosis or thrombocytopenia had developed after vaccination with ChAdOx1 nCov-19. Then they used a standard ELISA to detect platelet factor 4(PF4)heparin antibodies and a modified (PF4-enhanced) plateletactivation test to detect platelet-activating antibodies under various reaction conditions [2]. Included in their testing were samples from patients who had blood samples referred for investigation of vaccine-associated thrombotic events, with 28 testing positive on a screening PF4–heparin immunoassay. Of the 11 original patients, 9 were women, with a median age of 36 years. Beginning 5 to 16 days after vaccination, the patients presented with one or more thrombotic events, except for 1 patient, who presented with fatal intracranial hemorrhage [2]. When reading and reviewing this clinical study report (with all due respect), the first impression is which guidelines, and standard procedures they have followed to acquire processed data? And why do they use certain random procedures then? Remarkably, this paper and acquired data were published in the NEJM 2021 with 218 citations (with all due respect). There are so many question marks remaining, at the end of the day. In another paper is suggesting that although, the mRNA vaccines have the benefits of being elastic and competent in immunogen intentions, engineering, and currently several vaccine manufacturers are in various stages of progressing and claiming another novel vaccine, which is more effective than previous ones, controversially. Nonetheless Markus Aldén et al. 2021 preclinical studies over the COVID-19 mRNA vaccine BNT162b2, which was developed by Pfizer and BioNTech, showed reversible hepatic effects in animals that received the BNT162b2 injection [4]. Additionally, an up-to-date study showed that SARS-CoV-2 RNA can be reverse-transcribed and integrated into the genome of human cells [4]. Their results are indicating a fast up-take of BNT162b2 into the human Hepatic cell line Huh7, leading to changes in LINE-1 expression and distribution. They also confirmed that BNT162b2 mRNA is reverse transcribed intracellularly into DNA in, as fast as 6 hours upon BNT162b2 exposure [4]. One straight question is why with “vaccines” manufacturers gave different incorrect information (un-)intentionally? Why they did not follow standard vaccine production-good-guidelines and standard procedures, with ‘gods’ sake, that could be used for human? A short answer might be that a vaccine was urgently needed [5].

Take home message is why after 2022, we are not using a good guideline based on facts and standard procedures, which can be repeated by other researchers, The guidelines are made to be precise/informative/ validated/ Science-based and factual, which they should increase the trust of any random Academic toward manufacturers, considerably. What we were experiencing in the last decade, especially during COVID-19 pandemics, were disastrous approaches from COVID-19 controversial guidelines introduced by unknown research and economic-based managers. Soon, it will be clear how and why the complex and controversial guidelines are dominating the medicine and vaccines markets.

1. Pramesh CS, Babu GR, Basu J, Bhushan I, Booth CM, Chinnaswamy G, et al. Choosing Wisely for COVID-19: ten evidence-based recommendations for patients and physicians. Nat Med. 2021;27(8):1324-7. PubMed | CrossRef

2. Greinacher A, Thiele T, Warkentin TE, Weisser K, Kyrle PA, Eichinger S. Thrombotic thrombocytopenia after ChAdOx1 nCov-19 vaccination. New Eng J Med. 2021;384(22):2092-101. PubMed | CrossRef

3. Badlou BA. COVID-19 War, Economic-Based Sciences. CPQ Medicine. 2020;10(6),01-03. CrossRef

4. Aldén M, OlofssonFalla F, Yang D, Barghouth M, Luan C, Rasmussen M, et al. Intracellular reverse transcription of Pfizer BioNTech COVID-19 mRNA vaccine BNT162b2 in vitro in human liver cell line. Curr Issues Mol Biol. 2022;44(3):1115-26. CrossRef

5. Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. 2020;586(7830):589-93. PubMed | CrossRef